CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 34 enrolled
Drug / intervention
Donepezil HCl +1 moredrug
Likely dose
Donepezil HCl 5 mg daily for 4 weeks, then 10 mg dailyAI-extracted
Key inclusion· 3
  • ✓Diagnosis of Autism Spectrum Disorder or Asperger's Disorder
  • ✓IQ of 75 or above
  • ✓Baseline assessment tests within acceptable range
Key exclusion· 5
  • ✕Bipolar disorder, schizophrenia, schizoaffective disorder, or psychotic disorder
  • ✕Seizure disorder requiring anticonvulsant medications
  • ✕Congenital rubella, cytomegalovirus, or tuberous sclerosis
  • ✕Medications that interact with donepezil HCl

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00047697
NCT00047697Phase 2Completed
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Donepezil HCl: Treating Cognitive Deficits in Autism

University of Pittsburgh·interventional·Posted Oct 16, 2002·Updated Oct 5, 2017

In Brief

A Phase 2 clinical trial evaluating Donepezil HCl and Placebo for Autistic Disorder. Completed, enrolled 34 participants across 1 site.

Detailed Summary

This 11-week study will examine the safety and effectiveness of the medication donepezil (Aricept®) compared to placebo for treating cognitive deficits in children and adolescents with Autism Spectrum Disorder.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAutistic Disorder
CountriesUnited States
CollaboratorsNational Institute of Mental Health (NIMH)

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 16, 2002
Enrollment StartOct 1, 2002
Primary CompletionAug 1, 2006
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 23.7 years ago

Interventions

Donepezil HCldrug

Participants will start with 5 mg per day dose of donepezil HCl, then have their dose increased to 10mg per day after 4 weeks.

Placebodrug

Placebo used in placed of Donepezil HCL